Multiple Applications of ExpressGraft-C9T1 Skin Tissue as a Treatment for Diabetic Foot Ulcers

An Open-Label, Prospective, Safety, and Tolerability Study of ExpressGraft- C9T1 Skin Tissue in the Treatment of Diabetic Foot Ulcers

Some people with diabetes get foot ulcers that do not heal. These ulcers can get infected and cause other medical problems.

Five patients with these foot ulcers volunteered to participate in the first part of this study (C9T12015, NCT02657876). They are called Cohort 1 in this registration. Cohort 1 received one application (piece) of an experimental skin tissue to make sure it was safe.

This study will extend the safety test of the experimental skin tissue. It will find out if it is safe to use more than once to cover non-healing ulcers.

This extension will include two more groups, Cohort 2 and Cohort 3. Cohort 2 may get up to 5 applications. Cohort 3 may get up to 10 applications. The number of applications will depend on how well the wound is healing.

Participants will be in the study up to one year.

Study Overview

• Status: Terminated
• Conditions: Diabetes; Diabetic Foot Ulcer; Non-healing Wound
• Intervention / Treatment: Biological: ExpressGraft-C9T1 Skin Tissue

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Titan Clinical Research
  • California
    • Fresno, California, United States, 93710
      • Limb Preservation Platform, Inc.
    • San Francisco, California, United States, 94115
      • Center For Clinical Resarch
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Center for Advanced Research & Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Volunteers will be consented. Then there will be a run-in period for the doctor to run some tests. If the tests show the study would be good for the patient, the doctor will enroll them as participants in the trial.

Inclusion Criteria:

To be considered for inclusion, a participant:

• Agrees to practice birth control for the duration of the study
• Has documented Type 1 or Type 2 diabetes and an HbA1C score of 10 or below
• Has protocol-defined sufficient blood pressure and flow to the foot
• Has stable medications for 2 weeks before treatment (other than diabetes medications or antibiotics)
• Is able and willing to attend scheduled visits and comply with study procedures
• If a smoker, agrees to try quitting and will accept counseling for it (Cohorts 2 and 3 only)
• Has documented informed consent for study enrollment
• Has had an uninfected, appropriately-sized diabetic ulcer on the foot for at least 4 weeks but not more than 1 year

Exclusion Criteria:

The doctor may not consider for inclusion a participant who:

• Is pregnant, nursing, or a prisoner
• Has had osteomyelitis in the foot with the ulcer in the last 30 days
• Has a history of poor compliance
• Has received drugs or therapies not allowed per protocol
• Has used an investigational product within the last 60 days
• Has ever received therapy for the study ulcer with any cell and/or tissue product (CTP)
• Has a study ulcer in a condition not appropriate for the study
• Has a medical condition or history that, per protocol or in the opinion of the study doctor, might put the safety of the participant in danger

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: One Application; Participants enrolled in Cohort 1 received one application of experimental skin tissue during the first part of this trial (NCT02657876)	Biological: ExpressGraft-C9T1 Skin Tissue; A round patch of experimental skin tissue that the doctor applies over the ulcer; Other Names: Experimental skin tissue
Experimental: Cohort 2: Up to Five Applications; Participants enrolled in Cohort 2 may receive up to 5 applications of experimental skin tissue as required for wound healing	Biological: ExpressGraft-C9T1 Skin Tissue; A round patch of experimental skin tissue that the doctor applies over the ulcer; Other Names: Experimental skin tissue
Experimental: Cohort 3: Up to Ten Applications; Participants enrolled in Cohort 3 may receive up to 10 applications of experimental skin tissue as required for wound healing	Biological: ExpressGraft-C9T1 Skin Tissue; A round patch of experimental skin tissue that the doctor applies over the ulcer; Other Names: Experimental skin tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events at Week 12	Clinically significant vital signs, infection, blood chemistry, hematology and immunological evaluations are recorded as adverse events	at Week 12
Number of participants with adverse events through study completion	Clinically significant vital signs, infection, blood chemistry, hematology and immunological evaluations are recorded as adverse events	at approximately 12 months

Collaborators and Investigators

• Sponsor: Stratatech, a Mallinckrodt Company
• Investigators: Study Director: Global Clinical Leader, Stratatech, a Mallinckrodt Company

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2019
• Primary Completion (Actual): November 25, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: October 18, 2019
• First Submitted That Met QC Criteria: October 18, 2019
• First Posted (Actual): October 22, 2019

Study Record Updates

• Last Update Posted (Actual): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: C9T12015 (Extended)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No